EMA Approves Pfizer-BioNTech Covid Vaccine

23.12.2020 - The European Medicines Agency (EMA) on Dec. 21 provisionally cleared EU-wide use of the Pfizer-BioNTech Covid-19 vaccine, which will be marketed under the brand name Comirnaty. The Conditional Marketing Authorization paves the way for a rollout across the 27 member states, which is slated to begin by the end of the month and is expected to be a major logistics challenge.

Before distribution of a vaccine – or any other drug – can begin, the EMA’s decision must be approved by the European Commission (EC) after consultation with all member states. The approval paperwork also must be translated into the EU’s 24 official languages, and each batch of vaccine validated before it can be shipped. Each country then will determine its own procedures for domestic distribution and administration.

Commenting on the timetable for vaccinations, EMA executive director, Emer Cooke, said it will take time to roll out vaccines in sufficiently large numbers to enable all citizens to be protected. Nonetheless, “the authorization of this first vaccine is definitely a major step in the right direction and an indication that 2021 can be brighter than 2020,” she stressed.

A newly created EU advisory vaccine body will underpin the Commission’s vote, which was planned to be announced within 24 hours. As the EMA has limited technical staff, Germany’s Paul Ehrlich Institute, which has worked with BioNTech in the past, has been charged with issuing certification papers for the vaccine.

An assessment report, with details of EMA’s evaluation of the vaccine and a full risk management plan is expected to be published shortly. Data from clinical trial data submitted for the marketing authoritzation will subsequently be published on the Agency’s clinical data website.

With the pathway for the Pfizer-BioNTech vaccine cleared, the European equivalent of the US Food and Drug Administration, which moved from London to Amsterdam due to Brexit, is expected to clear Moderna’s Covid vaccine candidate at its meeting on Jan. 6, 2021.

Europe’s conditional marketing authorization is similar to the emergency use authorizations that have been issued for the two candidates in the US and UK, with slightly varying terms. initially valid for one year, it can be renewed annually, but the EMA can revoke it at any time during the initial five-year period if new data shows that a vaccine’s benefits no longer outweigh its risk.

As for any other medicine, the annual renewal of EU vaccine marketing permission is contingent on manufacturers complying with specific information requirements within a defined timeframe. The companies will have to submit monthly safety reports in addition to the mandated regular updates and conduct studies to monitor the safety and effectiveness of the vaccines. Medical authorities will also conduct studies.

The European Commission has ordered 300 million doses of the two-dose Comirnaty through the end of 2021. It has also bought 160 million doses of Moderna’s double-dose vaccine. Inoculation of all 450 million people living in the EU could take months, though, European health officials say, and supply could be limited. The European population is comparatively older, meaning there are more people are at risk.

Germany, the EU’s most populous member state, has said it plans to vaccinate about 6.5 million people before Apr. 1. Priority will be given to those over age 80, patients with serious health conditions and healthcare staff. As eight million people are in this category, authorities expect a shortfall unless more vaccines are approved or more doses made.

Earlier this month, the EMA began a rolling review of Johnson & Johnson’s candidate, which  is still in late-stage clinical trials and not expected to be authorized before February 2021 at the earliest. Details from the AstraZeneca Phase 3 trials are so sketchy that it is anybody’s guess when that will be approved, reports suggest.

German biotech CureVac has started a Phase 2b/3 clinical trial of its Covid-19 vaccine candidate CVnCoV. The study is aimed at generating data to support approval of the company’s mRNA vaccine in2021, whereby a target date has not been disclosed.

BioNTech will test its vaccine for new virus variant

On the same day as EU approval for Pfizer-BioNTech was announced, news emerged of a new and potentially more infectious mutation of the coronavirus currently circulating in Europe, which has already led to a physical lockdown of the UK.

The discovery, which has not been verified in a lab, has raised concerns about the efficacy of the vaccines due to be rolled out in Europe.  “At the moment we can say that there is no evidence to suggest that the vaccine will not work against the new variant of the coronavirus,” Cooke said.

While noting that Biontech doesn’t believe that efficacy of its vaccine (to which it owns all rights) will be affected, CEO Uğur Şahin said it will conduct tests over the next two weeks. If these show that Comirnaty is not effective against the new variant, the company expects to be able to adapt it within six weeks.

Moderna said it also would test its vaccine’s efficacy against the new strain.

Author: Dede Williams, Freelance Journalist